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BRIAN PERRELLA
CHERYL PEDOTA
Prabhdeep Singh
USA

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Manager - Safety Compliance Reporting Job

Date: May 31, 2019

Location: Plainsboro, NJ, US

Company: Novo Nordisk

About the Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk Inc (NNI) is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the Food & Drug Administration (FDA) to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?


The Position
To contribute and support activities related to Adverse Event reporting and quality tasks in order to ensure consistency and compliance in all activities performed by Product Safety. To ensure maintenance and development of quality activities in Product Safety including, but not limited to the following: compliance tracking, contractual arrangement support and vendor support in regards to safety reporting.


Relationships
This position reports to the Director, Case Review & Compliance Reporting within Product Safety. This position works closely with all units in Product Safety, NNI Quality Assurance (QA), NNI Commercial, NNI Finance as well as Global Safety. Interacts with senior external contacts on significant matters, including the FDA, customers and vendors.


Essential Functions
  • Exercise considerable latitude and applies extensive technical expertise in determining and implementing strategies consistent with the unit’s functional and corporate goals
  • Prepare non-conformity reports when appropriate
  • Responsible for ensuring regular review and maintenance of Product Safety GlobeShare site
  • Responsible for preparation of monthly and annual Time Limit Exceeding Memo for Head of Product Safety/QA Department. Memos require analysis of late reports that occur during the month, prepare root cause analyses, review data for trends and make recommendations for process changes and other corrective actions to prevent future late reporting and improve FDA reporting compliance
  • Collaborate with other departments within Product Safety, other business areas at NNI and Global Safety to ensure late reports have been correctly identified and reported to management. Direct employees on proper root cause analysis, identification and documentation
  • Support internal and external training activities, such as Introduction program for new employees in Product Safety, safety training for all employees in NNI, and safety Training at Point of Action (POA)
  • Perform review of contracts with vendors involved in customer related activities on behalf of Novo Nordisk
  • Provide guidance to contract owners and other stakeholders on safety reporting requirements, including Safety Data Exchange Agreements
  • Liaise with outside vendors and corporate partners on electronic safety monitoring and reporting issues as appropriate
  • Provide Product Safety overview of Patient Support Programs, Market Research Programs, Other Customer Engagement Programs and Partners
  • Responsible for preparation of internal monthly reports for Product Safety management and, as needed, Executive Team (ET) and CMR
  • Guide the successful completion of major programs and may function in a project leadership role
  • Ensure compliance with all Federal regulations and company Standard Operating Procedures (SOPs) regarding adverse event reporting from both post-marketing sources and clinical trials complaint handling
  • Assist with the processing and submission of expedited safety reports. Collect, review and edit documents necessary for safety reporting sections of periodic and annual reports
  • Develop and maintain company (safety) SOPs
  • Develop applicable Adverse Event training programs
  • Maintain high state of knowledge of Adverse Event regulations, guidelines and standards related to Adverse Event surveillance and regulatory reporting
  • Participate in Promotional Review Board (PRB) meetings for all assigned Novo Nordisk products
  • Liaise with outside vendors and corporate partners on safety monitoring issues as appropriate
  • Serve as primary contact, facilitator and communicator of information to other departments within NNI and NNAS concerning adverse events and technical complaints

Physical Requirements
0-10% overnight travel required.


Qualifications
  • A Bachelor’s Degree in science area with a minimum of 8 years’ experience required; or a Registered Nurse (RN) or R.Ph with a minimum of 5 years’ experience, including 3 years in clinical and/or safety reporting. Advanced degree preferred
  • An MD in lieu of RN or Bachelor’s would be acceptable equivalent experience
  • Database and word processing experience
  • Excellent oral and written communication skills
  • Knowledge of diabetes and diabetes management
  • Knowledge of FDA safety and Good Manufacturing Practice (GMP) regulations
  • Prefer experience leading projects in a clinical and/or safety area
  • Previous pharmaceutical industry experience preferred

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.


Requisition ID: 59937BR
State/Provinces: Plainsboro
Job Category: Regulatory


Nearest Major Market: New Jersey

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